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FDA ANDA · ANDA077578

FINASTERIDE

Sponsor: MYLAN

APPLICATION
ANDA077578
TYPE
ANDA
ORIGINAL APPROVAL
2006-12-18
LATEST ACTION
2014-09-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

FINASTERIDEDiscontinued
FINASTERIDE 5MG · TABLET · ORAL

Approval history

2014-09-26Labeling · Supplement 14 · standardAP
2014-09-26Labeling · Supplement 13 · standardAP
2014-02-26Manufacturing (CMC) · Supplement 11AP
2011-03-31Labeling · Supplement 9AP
2006-12-18OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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